Endoscopic resection devices and related methods of use

ABSTRACT

Described is a tissue resection system which includes a guide element; a resection head; a positioning mechanism and an actuating mechanism. The resection head includes a guide channel slidably receiving the guide element and an endoscope channel sized to slidably receive an endoscope therein, so that, when the resection head is slid along the guide element, the endoscope and the resection head follow a path defined by the guide element. The positioning mechanism moves the resection head relative to a distal end of the endoscope between a first position in which the distal end of the endoscope extends distally out of the endoscope channel and a second position in which the distal end of the endoscope is received within the endoscope channel. The actuating mechanism moving a portion of an outer wall of the resection head to open and close a resection chamber defined by the outer wall.

PRIORITY CLAIM

The present application is a Continuation application of a U.S. patentapplication Ser. No. 10/639,229 filed Aug. 12, 2003, now U.S. Pat. No.7,014,646 entitled “Endoscopic Resection Devices and Related Methods ofUse” which is a Divisional application of U.S. patent application Ser.No. 09/939,407, filed Aug. 24, 2001, now U.S. Pat. No. 6,632,227,entitled “Endoscopic Resection Devices and Related Methods of Use”. Theentire disclosures of these prior patents/applications, are consideredas being part of the disclosure of the accompanying application and arehereby expressly incorporated by reference herein.

1. FIELD OF THE INVENTION

The present invention relates generally to full-thickness resectiondevices (FTRDs) and methods of using such devices to perform localizedresections of lesions in organs, for example, substantially tubularorgans such as the colon. The present invention has particularapplication to transanal and transoral surgical procedures, although itis not limited thereto.

2. DESCRIPTION OF THE RELATED ART

Resection procedures involve excising a portion of an organ,approximating the surrounding tissue together to close up a hole createdthereby, and removing any excess tissue caused by the approximation.Various conventional devices and procedures are available for resectinglesions in substantially tubular organs.

For example, several known resection devices and procedures require atleast one incision in an area near the portion of the organ to beexcised. The incision is required to allow the physician to access theorgan section to be excised and guide the device to that section. Theincision permits access to the lesion or treatment site for theseresection devices which do not have sufficient steering and/or viewingcapabilities to appropriately access the site without such a surgicalopening thereto. Thus, when an organ section to be excised is beyond thereach of such a device, or the device is not flexible enough to windthrough the organ to the site to be excised, an incision will berequired to position the device for the procedure. Of course, incisionsare traumatic to the patient and may involve a partial or entire loss ofmobility to the patient while recuperating from the incision, inaddition to recovering from the resection procedure itself. The timerequired to recover from such a procedure also is often longer than forprocedures which do not require incisions.

One type of conventional resection procedure utilizes a circularstapling instrument in which a tubular section of a tubular organ (inother words, a length of the organ) is excised, resulting in the tubularorgan being separated into first and second segments. The end sectionsof the first and second segments are tied closed, in for example apurse-string fashion, and stapled together. The tissue of the“purse-stringed” end sections radially inside the line of staples isthen cut off. In this circular anastomosis procedure, at least oneseparate invasive incision is typically made near the section to beexcised in order to cut out the section to be removed and to pursestringthe ends of the first and second sections of the organ. Also, a separateincision may be needed to place a first part of the resection device inthe first segment and a corresponding second part of the device in thesecond segment (e.g., anvil in one segment and stapling head in theother) so that the device may bring the first and second segmentstogether and staple them together. Thus, this type of resectionprocedure involves the drawbacks mentioned above in regard to proceduresrequiring invasive incisions as well as additional complicationsresulting from the removal of an entire tubular segment of the organincluding, for example the risk of spillage of nonsterile bowel contentsinto the sterile body cavity, which can cause severe infection andpossibly death.

An alternative resection device includes a stapling and cutting assemblyon a shaft which can be bent or formed into a desired shape and theninserted into a patient's body cavity. Once the shaft has been bent intothe desired shape, the rigidity of the shaft ensures that shape ismaintained throughout the operation. This arrangement limits theeffective operating range of the device as the bending of the shaft intothe desired shape before insertion and the rigidity of the shaft oncebent require the physician to ascertain the location of the organsection to be removed before insertion, and deform the shaftaccordingly. Furthermore, the rigidity of the shaft makes it difficultto reach remote areas, particularly those areas which must be reached bya winding and/or circuitous route (e.g., the sigmoid colon). Thus, anincision may be required near the organ section to be excised in orderto position the device at that organ section.

Furthermore, devices have been described in U.S. Pat. Nos. 6,119,913 and6,126,058 including resectioning means guided through the colon using aflexible endoscope. Although these devices describe the removal oflesions beyond the splenic flexure of the colon, removals in theselocations are limited to pendunculated-type polyps a stem of which maybe severed by a snare or very small polyp-type tumors that can beremoved using what are essentially biopsy devices (limited to mucosaldepth only).

To help describe this, FIG. 1 shows the general shape of a portion of acolon 10 up to the cecum. The colon 10 has the following main sections:the rectum 11, the sigmoid colon 12, the descending colon 13, thesplenic flexure 14, the transverse colon 15, the hepatic flexure 16, theascending colon 17, and the cecum 18. The small bowel 19, or ilium,connects to the cecum 18, as shown in FIG. 1. Prior art resectiondevices purport to navigate the colon 10 up to the splenic flexure 14,but no further due to the right angle turn at the splenic flexure. Turnswithin the sigmoid colon 12 are described as being navigated andstraightened by current endoscopy techniques allowing these devices totravel past the sigmoid colon 12. However, existing resection devices,which do not have steering capability or sufficient flexibility, must bepushed along the colon and rely on the colon wall to guide them. Pushingbeyond the splenic flexure 14 significantly increases the risk ofdamaging the colon by, for example, tearing its wall. Thus, lesionsbeyond the splenic flexure that cannot be removed with a simple biopsydevice are typically removed by open or laparoscopic surgery. To do so,a colonoscope is inserted in the rectum and guided to the section of thecolon where the lesion is located. That section of the colon then ismarked with a dye so the surgeon may determine what tissue is to beremoved during surgery.

SUMMARY OF THE INVENTION

The present invention is directed to a resection head for endoscopicresection of tissue comprising an endoscope receiving channel extendingtherethrough so that an endoscope may be slidably received therein and afirst position adjusting mechanism for moving the resection headrelative to an endoscope received in the endoscope receiving channelbetween a first retracted position in which a distal end of theendoscope extends beyond a distal end of the resection head and adeployed position in which the distal end of the endoscope is receivedwithin the endoscope receiving channel. The resection head alsocomprises a resection chamber within an outer wall of the resectionhead, at least a first portion of the outer wall being moveable withrespect to a second portion thereof to open the resection chamber to anexterior of the resection head and a resection mechanism for resectingtissue received within the resection chamber.

The present invention is also directed to a method of resecting tissuecomprising the steps of coupling a distal end of a flexible guide to adesired location on a wall of a body lumen and sliding a resection headcoupled to an endoscope over the guide to the desired location, whereinthe resection head is coupled to an endoscope with the flexible guideextending outside of the endoscope between an entrance to the body lumenand the desired location. A selected portion of tissue to be resected isthen drawn into a resection area of the resection head and resected.

It is to be understood that both the foregoing general description andthe following detailed description are exemplary and explanatory onlyand are not restrictive of the invention, as claimed.

BRIEF DESCRIPTION OF THE DRAWINGS

The accompanying drawings, which are incorporated in and constitute apart of this specification, illustrate several embodiments of theinvention and together with the description, serve to explain theprinciples of the invention.

FIG. 1 is a plan view showing the various portions of a colon;

FIG. 2 is a cross-sectional view of the colon showing an FTRD accordingto an embodiment of the present invention along with a guidewire affixedto a portion of the colon near a lesion to be resected;

FIG. 3 is a cross-sectional view of the colon showing the deployed FTRDof FIG. 2;

FIG. 4 is a cross-sectional view of the colon showing the deployed FTRDof FIG. 3 in a tissue receiving position;

FIG. 4 a is a cross-sectional view of the colon showing anotherembodiment of an FTRD according to the present invention, where asuction line is provided to apply suction to an internal cavity of ahead of the FTRD for drawing a lesion into the head for resection;

FIG. 5 is a plan view of another FTRD according to an embodiment of thepresent invention, with a spring loaded head extension arm;

FIG. 6 is a plan view of another FTRD according to an embodiment of thepresent invention, with a radial viewing channel;

FIG. 7 a is a plan view of yet another FTRD according to an embodimentof the present invention, with a guidewire channel formed into the head;and

FIG. 7 b is a cross-sectional view of the head shown in FIG. 7 a takenthrough line A-A and rotated 90 degrees.

DESCRIPTION OF THE EMBODIMENTS

Reference will now be made in detail to the present embodiments of theinvention, examples of which are illustrated in the accompanyingdrawings. Wherever possible, the same reference numbers will be usedthroughout the drawings to refer to the same or like parts.

The surgical resection devices according to the present invention willbe shown and described with reference to use within the colon. The uses,however, are not so limited, as the devices may be used in various otherhollow organs throughout the body, including, for example, theesophagus, stomach, and small bowel.

The present invention provides endoscopic surgical devices and relatedmethods of their use that permit the devices to navigate a tortuous bodylumen, including its sharp turns, through the use of a guide, such as aguidewire, for example. Instead of using the body lumen itself to guidethe endoscope and resection device, the guidewire may be used to definea path allowing the resection device to navigate sharp turns withoutimpinging upon the wall of the lumen to avoid damage to the organ wall.

FIG. 2 shows an FTRD 20 according to an embodiment of the presentinvention. FTRD 20 is shown on a distal end of an endoscope 30. FTRD 20has a rounded head 21 to allow for easier and safer navigation throughthe colon. A body portion 22 of FTRD 20 sits adjacent and proximal tohead 21 and during navigation rests against a stop ring 31 located in afixed position on endoscope 30. This stop ring may be made of a plasticor any other suitable biocompatible material known in the art.

A guidewire 40 is anchored to the colon wall 60 in a location near alesion 50 (shown as a diseased portion of colon wall 60) to be resected.FTRD 20 is capable of resecting a range of lesion types, such as polypsor other types of lesions known to occur in body lumens. FTRD 20 of thecurrent invention may be especially useful in resecting lesions, such aslesion 50, that previously could be removed only using invasive surgicaltechniques.

In practice, an operator may use a colonoscope (not shown) to navigateto the area of lesion 50, in a conventional fashion as is known in theart. Once the target area has been located using the colonoscope, aguidewire 40 may be inserted therethrough to this target area. Ofcourse, the guidewire 40 may be inserted within the colonoscope as thecolonoscope is maneuvered to the target area. However, this may make itmore difficult for the operator to freely maneuver the colonoscope alongthe route to the target area. Preferably, the colonoscope is guidedthrough the colon 10 to the location of lesion 50 and then guidewire 40is inserted afterwards. Once the operator has located lesion 50 usingtechniques common with the use of a colonoscope, guidewire 40 may beaffixed to the wall of the colon to act as a guide for FTRD 20 to reachthe location of lesion 50. Guidewire 40 may be affixed to the colon wallusing any suitable fixation device and method known in the art,including, for example, a hook, grasper jaw, suction, staple, or clampadhesive. Once guidewire 40 has been anchored in place, the colonoscopemay be removed.

Then an endoscope 30 with stop ring 31 mounted thereon and the FTRD 20attached thereto distally of the stop ring 31 is inserted into thecolon. A proximal end of the guidewire 40 is inserted into a guidewirechannel 41 extending through the FTRD 20 and the operator may theninsert the FTRD 20 and endoscope 30 into the colon with the guidewire 40directing the path of travel as they are slid therealong. FTRD 20 andendoscope 30 may preferably be pushed along the length of the colon withthe guidewire 40 defining the path along which they move therethrough.FTRD 20 may also be provided with any suitable, known advancing means topull FTRD 20 and endoscope 30 along guidewire 40 to the desiredlocation. However, while advancing the endoscope 30 and guidewire 40,tension on the guidewire 40 should be minimized to decrease the risk ofinverting the colon.

As shown in FIG. 3, once FTRD 20 has reached lesion 50, it may be movedinto a deployment position. Attached to stop ring 31 are two arms 23.These arms 23 allow FTRD 20 to extend past the distal end of endoscope30 to a position proximate to lesion 50. Once in this position, aresection chamber may be opened to receive therein the tissue to beresected as will be described in more detail below. According to thepresent embodiment, arms 23 are activated by, for example, an hydraulicforce applied via an actuator (not shown) located at a proximal end ofthe FTRD which remains accessible to the operator (i.e., outside of thepatient) during the procedure. However, those of skill in the art willunderstand that the arms 23 may be extended to move FTRD 20 away fromring 31 by any of various actuating mechanisms such as, e.g., a cableand pulley mechanism, a rotating drive shaft and gearing mechanism, etc.In order to maintain a smooth outer profile of the body 23, prior todeployment, the arms 23 are received in channels (not shown) formed inthe body 22. The operator then activates an arm 25 a (which may also beactuated by, for example, hydraulic force) within FTRD 20 to separatehead 21 from body 22 and open a resection chamber 24, as depicted inFIG. 4, to the interior of the organ. When the procedure has beencompleted, the operator may operate the arms 25 a and 25 b in thereverse direction using hydraulic force to close the resectioningchamber 24 and retract the FTRD 20 so that the distal end of theendoscope 30 protrudes therefrom.

As seen in FIG. 5, as an alternative to arm 25 a, a shaft 25 b may befitted into an opening 26 within body 22 with a spring 27 receivedtherearound biasing the head 21 into a separated configuration. A latchmechanism (not shown) maintains head 21 and body 22 together in a closedconfiguration until an operator releases the latch by, for example,actuating a pull cable (which extends to the proximal end of the device)allowing the spring 27 to expand and cause head 21 to separate therebyopening the resection chamber 24 to the interior of the organ.

Lesion 50 is then drawn into resection chamber 24 by any suitable meansknown in the art, such as applying suction to draw lesion 50 intoresection chamber 24. This is depicted, for example, in an embodimentaccording to the present invention shown in FIG. 4 a. In the FTRD 20shown in FIG. 4 a, head 21 may be provided with an open cavity 29 and aduct 27 a containing one or more suction openings 27 b. Duct 27 a isconnected to a vacuum source outside the patient via suction channel 27.Suction channel 27 may run through arm 25 a (as shown in FIG. 4 a) or itmay run alongside arm 25 a. Channel 27 then extends through body 22 andoutside body 22 along or within endoscope 30. In this embodiment, anoperator my activate the vacuum source thus creating suction at each ofthe suction openings 27 b. This suction will then be used to draw lesion50 into cavity 29 to then be resected.

Other means for drawing lesion 50 into resection chamber 24 may includea grasper used to grasp guidewire 40 and pull the lesion into chamber24, or a snare used to grasp a knot or sinker affixed to guidewire 40and retract lesion 50 into resection chamber 24 by pulling guidewire 40into resection chamber 24.

Once lesion 50 has been drawn into the chamber 24, arm 25 a may beactuated to close resection chamber 24 pinching the tissue surroundingthe lesion 50 between the head 21 and the body 22. This tissue is thenstapled together so that, when the lesion 50 is resected, the organremains sealed. After the tissue has been successfully stapled, orotherwise joined together, the lesion and other tissue radially withinthe line along with the tissue is joined is resected and the FTRD 20releases the stapled tissue so that the body 22 and the head 21 move tothe fully closed position retaining the tissue of the lesion 50therewithin so that it may be analyzed upon removal from the body.

The resection of the tissue may be performed by any suitable resectionmechanism, such as, for example, providing a staple chamber within body22 and an anvil within head 21 as is in current FTRD's. After resectionof lesion 50, the operator may close the resectioning chamber 24 byretracting the arm 25 a or 25 b and then retract the FTRD 20 distally tothe stop ring 31 by drawing the arms 23 back. The FTRD 20, endoscope 30,and guidewire 40 may then be removed from the patient with the resectedtissue held in the resection chamber 24.

Head 21 may be made of a transparent material to allow the operator tomake position adjustments even after the FTRD 20 has been configured inthe deployed position with the distal end 32 of the endoscope 30retracted therein. To make visual observations of the position of theFTRD 20, the end 32 of endoscope 30 may include light and visualizationdevices as are known in the art. The steerable and flexible distal tipof the endoscope 30 allows the operator to maneuver the tip looksubstantially distally through distal end of head 21 or to turn the tipaway from a longitudinal axis of the endoscope 30 to view selectedportions of the organ wall through the transparent head 21.

In another embodiment according to the present invention as seen in FIG.6, a head 121 is formed of material which need not be transparent.However, an endoscope channel 128 is formed within head 121 and body122, and a radial viewing port 129 is also formed in the head 121, asseen in FIG. 6. Port 129 may be either an open port or it may be coveredby a transparent window. A resection chamber 124 may be opened byactivating an arm 125.

FIGS. 7 a and 7 b show a head 221 of an FTRD 20 according to anotheraspect of the invention. Head 221 includes an endoscope channel 228 andalso a guidewire channel 225 that communicates with a groove 226 formedin head 221. While navigating the FTRD 20 through a body lumen,guidewire 40 may rest in channel 225. However, once the FTRD has reachedthe area of the lesion 50, the operator may wish to move the head 221past the point at which the guidewire 40 is attached to the colon wall60. By providing groove 226 in communication with channel 225, guidewire40 may pass through groove 226 and out of head 221. This feature isespecially advantageous when guidewire 40 is affixed to the colon wallat a location just beyond lesion 50 or proximal to lesion 50. Ifguidewire 40 is affixed at a location far enough past lesion 50, thenguidewire channel 225 is sufficient and groove 226 is not needed, asguidewire 40 may still pass through the distal end of head 21 withoutinterfering with the resection procedure and hindering the entrance oftissue into the resection chamber.

In another variation on the procedure for using any of the FTRDembodiments, guidewire 40 may be affixed directly to lesion 50. In thisscenario, guidewire 40 may be used to pull lesion 50 into resectionchamber 24. Once FTRD 20 is in position proximate lesion 50, theoperator may pull guidewire 40 proximally into the FTRD 20 therebydrawing the lesion 50 into resection chamber 24. The procedure may thenbe completed as described above.

Other embodiments of the invention will be apparent to those skilled inthe art from consideration of the specification and practice of theinvention disclosed herein. It is intended that the specification andexamples be considered as exemplary only, with a true scope and spiritof the invention being indicated by the following claims.

1. A tissue resection system, comprising: a guide element; a resectionhead comprising a guide channel slidably receiving the guide element andan endoscope channel sized to slidably receive an endoscope therein, sothat, when the resection head is slid along the guide element, theendoscope and the resection head follow a path defined by the guideelement; a positioning mechanism moving the resection head relative to adistal end of the endoscope between a first position in which the distalend of the endoscope extends distally out of the endoscope channel and asecond position in which the distal end of the endoscope is receivedwithin the endoscope channel, the positioning mechanism including armsadvancing the resection head beyond the distal end of the endoscope; andan actuating mechanism moving a portion of an outer wall of theresection head to open and close a resection chamber defined by theouter wall.
 2. The tissue resection system according to claim 1, furthercomprising a stop ring of the endoscope to limit translational movementof the resection head along the endoscope.
 3. The tissue resectionsystem according to claim 1, further comprising a resection mechanismdisposed within the resection head.
 4. The tissue resection systemaccording to claim 1, further comprising a stapling mechanism forstapling together, prior to tissue resectioning, portions of tissueadjacent to tissue to be resectioned.
 5. The tissue resection systemaccording to claim 1, wherein the positioning mechanism comprises ahydraulic actuator.
 6. The tissue resection system according to claim 1,wherein the positioning mechanism comprises at least one of a cable andpulley mechanism and a rotating drive.
 7. The tissue resection systemaccording to claim 1, further comprising a source of suction to drawtissue into the resection chamber.
 8. The tissue resection systemaccording to claim 1, further comprising a grasper to draw the tissueinto the resection chamber.
 9. The tissue resection system according toclaim 1, further comprising a viewing port of the resection headproviding an observation path from the endoscope.
 10. The tissueresection system according to claim 9, wherein at least a portion of theouter wall is transparent.
 11. A method of resecting tissue, comprising:advancing a resection head into a body lumen to a lesion along a guideelement, the guide element engaging a guide channel of the resectionhead; monitoring progress of the resection head with an endoscopeinserted through an endoscope channel formed in the resection head;moving the resection head distally relative to the endoscope via apositioning mechanism including arms to extend a distal end of theresection head beyond a distal end of the endoscope, adjacent to thelesion; moving a portion of an outer wall of the resection head to opena resection cavity formed therein; drawing tissue to be resected intothe resection cavity; and resecting the tissue to be resected with aresection mechanism of the resection head.
 12. The method according toclaim 11, further comprising operating hydraulic actuators to move theresection head distally relative the endoscope.
 13. The method accordingto claim 11, wherein the arms are operatively connected to the resectionhead.
 14. The method according to claim 11, further comprising viewingthe tissue to be resected via a viewing port of the resection headaligned with a field of vision of the endoscope.
 15. The methodaccording to claim 11, further comprising opening the resection cavityby releasing a spring biased to move the portion of the outer wall.